Varenicline for Adolescent Smoking Cessation

Phase 3

Completed

Brief Summary: This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

Detailed Description: The objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. The guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. Participants will provide smoking self-report (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. After the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (Week 13, Week 18, and Week 26).

Recruitment & Eligibility

Inclusion Criteria

Age 14-21
Daily smoker for ≥6 months
Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

Exclusion Criteria

Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
Current substance dependence, other than nicotine
Current unstable major medical disorder
Current pregnancy or breastfeeding
Current use of medications with smoking cessation efficacy
Known hypersensitivity to varenicline

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Participants \>55 kg will take placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
varenicline	Varenicline	Participants \>55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-emergent Adverse Events	26 weeks (12 weeks of treatment plus full post-treatment follow-up)	Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.
Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment	7 days at end of treatment	Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit

Secondary Outcome Measures

Name	Time	Method
Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment	12 weeks of active treatment	Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment
Percentage of Post-treatment Visits With Abstinence	One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits	Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence.
Percentage of Visits With Abstinence During Treatment	12 weeks (all of active treatment)	Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence.